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ABT-126 in Subjects with Alzheimer's Disease on Acetylcholinesterase Inhibitors

Completed

This Phase II efficacy and safety study will evaluate the drug ABT-126 as a new treatment for people with mild to moderate Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 90 Years Both No
March 2012
October 2013
420

++Meets NINCDS/ADRDA criteria for probable Alzheimer's disease++Taking stable dose of an acetylcholinesterase inhibitor (donepezil or rivastigmine) for at least 90 days prior to screening++Mini-Mental Status Examination (MMSE) total score of 12 to 24; Cornell Scale for Depression in Dementia (CSDD) score of 10 or less; Modified Hachinski Ischemic Scale (MHIS) score of 4 or less++Good general health, based on results of medical history, physical examination, vital signs, laboratory profile, and electrocardiogram++Caregiver who will provide support, ensure compliance with study medication and procedures, and provide accurate information about the subject's status during the study

++Subject has taken galantamine or memantine within 60 days prior to screening++Clinically significant abnormal laboratory values at screening++History of any significant neurologic disease other than Alzheimer's disease, including Parkinson's disease, multi-infarct or vascular dementia, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, seizures++Mental retardation++History of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities++Clinically significant uncontrolled medical or psychiatric illness.

This is a Phase II study designed to evaluate the efficacy and safety of ABT-126 in older adults with mild to moderate Alzheimer's disease who are taking stable doses of acetylcholinesterase inhibitors. Participants will be randomized to receive one of two ABT-126 doses or a placebo for a 24-week treatment period. Participants in this study may be eligible to take part in a related extension study; see NCT01690195 in ClinicalTrials.gov for details.

For more information about this clinical trial or the study sites, call or email the study contacts Alison Torres (847-938-2226; alison.torres@abbott.com) or Betty Prine (847-937-6928; betty.prine@abbott.com).

Name City State Zip Status Primary Contact
Site Reference ID/Investigator# 66528
Fresno California 93720

Site Reference ID/Investigator# 69602
Long Beach California 90806

Site Reference ID/Investigator# 66527
San Francisco California 94109-4841

Site Reference ID/Investigator# 66530
Hamden Connecticut 06518

Site Reference ID/Investigator# 66522
Delray Beach Florida 33445

Site Reference ID/Investigator# 66524
Orlando Florida 32806

Site Reference ID/Investigator# 66531
Tampa Florida 33613

Site Reference ID/Investigator# 66529
West Palm Beach Florida 33407

Site Reference ID/Investigator# 66526
Elk Grove Village Illinois 60007

Site Reference ID/Investigator# 66525
Staten Island New York 10312

Site Reference ID/Investigator# 66523
Bennington Vermont 05201

Site Reference ID/Investigator# 71793
Gatineau J9A 1K7

Site Reference ID/Investigator# 71794
Montreal H3T 1E2

Site Reference ID/Investigator# 71798
Peterborough K9H 2P4

Site Reference ID/Investigator# 71795
Toronto M3B 2S7

Site Reference ID/Investigator# 71796
Verdun H4H 1R3

AbbVie (prior sponsor, Abbott)

Name Role Affiliation
Laura Gault, MD Study Director Abbott

Name Phone Email
Alison Torres 847-938-2226 alison.torres@abbott.com
Betty Prine 847-937-6928 betty.prine@abbott.com

NCT01549834

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors